Treatment of skin and soft tissue cancers using alpha radiation emitters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a novel treatment method using diffusing alpha radiation emitters (DaRT) for patients with superficial cutaneous, mucosal, or soft tissue neoplasms. The approach involves inserting radioactive seeds directly into the tumor, allowing for localized radiation therapy that aims to reduce tumor size while minimizing exposure to surrounding healthy tissue. The study will assess tumor reduction 70 days post-treatment and monitor adverse events to ensure patient safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* International normalized ratio of prothrombin time ≤1.8.
* Creatinine ≤1.9 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor of Keratoacanthoma histology.
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects not willing to sign an informed consent.
* Women who are pregnant or breastfeeding.

Where it's running

• RAMBAM Health Care Campus
  Haifa, Israel Recruiting

Study contacts

• Principal investigator: Tomer Charas, MD — Radiotherapy unit at Rambam Health Care Campus, Israel
• Study coordinator: Liron Dimnik
• Email: LironD@alphatau.com
• Phone: +972-2-373-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.